Effect of Acotiamide on Gastric Motility and Satiation in Healthy Volunteers

Universitaire Ziekenhuizen KU Leuven20 enrolled

Overview

Introduction. Functional dyspepsia (FD) is a common chronic gastrointestinal disorder with a high socio-economic impact. Acotiamide, a new prokinetic agent, was shown to be efficacious in the treatment of FD, especially in the postprandial distress syndrome subgroup. To date, the exact mechanism of action of acotiamide is incompletely elucidated. The aim of this study was to examine the effect of acotiamide on gastric motility, gastric emptying rate and gastrointestinal symptom perception in healthy participants in a randomized, placebo-controlled, cross-over study design. Participants were treated with acotiamide (100 mg t.i.d.) and placebo for 3 weeks, separated by a one-week wash-out period. At the end of each treatment period, gastric emptying and motility were assessed on two consecutive study days. During gastric motility assessment, epigastric symptom scores were collected at multiple time points.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Healthy

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * age: 18-60 years old. * Participant must provide witnessed written informed consent prior to any study procedures being performed. Exclusion criteria: * Age \> 60 years old. * severely decreased kidney function. * severely decreased liver function. * severe heart disease, for example a history of irregular heartbeats, angina or heart attack. * severe lung disease. * severe psychiatric illness or neurological illness. * any gastrointestinal disease. * any dyspeptic symptoms. * pregnant or breastfeeding.

Outcomes

Primary Outcomes

Gastric accommodation

Relaxation of the stomach upon food intake

Time frame: Gastric pressure was measured until 1 hour after the start of the liquid meal. Liquid meal started 10 minutes after medication/placebo intake

Secondary Outcomes

Gastric emptying

Gastric emptying was assess by a 13C-octanoid acid breath test

Time frame: Breath samples were collected before intake of medication/placebo and every 15 minutes until 4h after intake of 13C-octanoid acid

Change in subjective gastrointestinal symptom scores measured by visual analogue scale of 100 mm

Time frame: assessment by questionnaire (100 mm Visual Analogue Scale) every 5 minutes, up to 1 hour after administration of the liquid meal